Source document or public record
FDA 510(k) K203364 — MDPC-8127
FDA 510(k) index record K203364. Device: MDPC-8127. Applicant as listed: Barco N.V.. Decision date: 2021-04-15.
Source
"device_name": "MDPC-8127"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K203364.
Device name: MDPC-8127. Applicant as listed: Barco N.V..
Decision date: 2021-04-15. Decision wording: Substantially Equivalent.
Product code: PSY. Regulation: 21 CFR 864.3700. Medical specialty: Pathology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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